FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125257–125280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1990
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
K902261 · BTM
Ambu, Inc.
Anesthesiology · 56d
Cleared Jul 16, 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)
K902356 · DKJ
Eastman Kodak Company
Chemistry · 48d
Cleared Jul 16, 1990
BAG, URINE
K902417 · KNX
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 46d
Cleared Jul 16, 1990
MEADOX SURGIMED BIOPSY GUN AND NEEDLE
K902461 · KNW
Meadox Surgimed, Inc.
Gastroenterology & Urology · 42d
Cleared Jul 16, 1990
ACID PHOSPHATASE REAGENT SET
K902495 · CKB
Tech Intl. Co.
Chemistry · 41d
Cleared Jul 16, 1990
CARDS O.S. MONO
K902510 · KTN
Pacific Biotech, Inc.
Microbiology · 41d
Cleared Jul 16, 1990
DMAC INDOLE REAGENT
K902640 · JTO
Api Analytab Products
Microbiology · 32d
Cleared Jul 16, 1990
SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)
K902699 · JJW
Actio, Inc.
Chemistry · 27d
Cleared Jul 16, 1990
PASCO MIC AND MIC/ID MODIFIED
K902739 · JWY
Pasco Laboratories, Inc.
Microbiology · 26d
Cleared Jul 16, 1990
SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET
K902773 · FGB
Medical Engineering Corp.
Gastroenterology & Urology · 21d
Cleared Jul 16, 1990
CHEM-CHEX BILIRUBIN
K902867 · JJX
Streck Laboratories, Inc.
Chemistry · 17d
Cleared Jul 16, 1990
UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE
K902897 · LRM
United Biotech, Inc.
Immunology · 13d
Cleared Jul 13, 1990
SIEMENS SONOLINE AC
K896480 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 240d
Cleared Jul 13, 1990
UNSCENTED MENSTRUAL TAMPON
K897007 · HEB
Personal Products Co.
Obstetrics & Gynecology · 207d
Cleared Jul 13, 1990
THIN CONDOM RAMSES & SHEIK
K897140 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 198d
Cleared Jul 13, 1990
BSI MODEL TIP
K897191 · LHQ
Bales Scientific, Inc.
Radiology · 197d
Cleared Jul 13, 1990
TEMPORARY CROWN MATRIX BUTTONS
K900389 · EBG
Advantage Dental Products, Inc.
Dental · 165d
Cleared Jul 13, 1990
LIFE-TEL CELLULAR TRANSCEIVER
K900541 · DXH
Racom, Inc.
Cardiovascular · 158d
Cleared Jul 13, 1990
MODEL 9200 RESPIRATION/HEART RATE MONITOR
K901656 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 94d
Cleared Jul 13, 1990
MDL-2000 LASERTRIPTER
K901723 · LNK
Candela Laser Corp.
Gastroenterology & Urology · 88d
Cleared Jul 13, 1990
HELIOLUX VISIBLE CURING LIGHT
K901908 · EBZ
Ivoclar North America, Inc.
Dental · 78d
Cleared Jul 13, 1990
DENDIA WERK BURS AND CUTTING DISCS
K901967 · DZP
Micro-Aire Surgical Instruments, Inc.
Dental · 73d
Cleared Jul 13, 1990
SEAL RITE PROCEDURE KIT(TM)
K902023 · EBC
Pulpdent Corp.
Dental · 70d
Cleared Jul 13, 1990
AHYDRON DENTAL CLEANING AGENT
K902052 · EMA
Ivoclar North America, Inc.
Dental · 67d